AsthmaPhase 3GLIDENCT07671001
A Study of Depemokimab in Participants of 6 to 11 Years of Age
A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Depemokimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2026to 24 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who have a documented physician diagnosis of asthma for at least 12 months prior to Visit 1 that meets the National Heart, Lung, and Blood Institute guidelines [NHLBI, 2007] or Global Initiative of Asthma (GINA) guidelines [GINA, 2025] or Japanese Pediatric Guidelines for The Treatment and Management of Asthma [JPGL, 2023]
- Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater than or equal to (>=)300 cells/microliters (mcL) demonstrated in the past 12 months, or elevated peripheral blood eosinophil count of >=150 cells/ mcL at visit 1
- Participants who are >=15 Kilograms (kg) in body weight
- A well-documented requirement for regular treatment with inhaled corticosteroid (>=200 mcg/day fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). The Inhaled corticosteroids (ICS) dose should represent medium or high dose in children aged 6-11 years of age
- Current treatment with an additional controller medication for at least 3 months prior to screening [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline]. For Japan only: This inclusion criterion does not apply to the participants in Japan. As long as the ICS dose represent high dose, the current treatment or previous failure of an additional controller will not be required for eligibility
- Previously confirmed history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (CS) (intramuscular [IM], intravenous, or oral), in the 12 months prior to visit 1, despite the use of ICS. For participants receiving maintenance OCS, treatment for the exacerbations must have been a two-fold increase or greater in the CS dose
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- Male or eligible female
- A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies: Is prepuberal or having periods but no sexual activity or using an acceptable contraceptive method, if sexual activity. prior to and during the study intervention period (at a minimum until 35 weeks after the last dose of study intervention).
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a girl with an early undetected pregnancy
- The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant and the participant's assent, when applicable, before any study-specific activity is performed unless a waiver of informed consent has been granted by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC). All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand
- A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of activities (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant, as needed
Who cannot join
- Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake with the exception of oral CS for asthma, or immunodeficiency disorder
- Or presence of a known pre-existing, clinically important lung condition other than asthma
- Participants with other conditions that could lead to elevated eosinophils
- Participants who have known, pre-existing, clinically significant medical conditions that could affect the conduct of the study
- Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment
- Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero) or benralizumab (Fasenra) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1 or who have previous documented failure with anti- Interleukin-5 Receptor (IL5/5R) therapy
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- Participants who have received omalizumab (e.g., Xolair, Omlyclo), tezepelumab (Tezspire) or dupilumab (Dupixent) within 130 days or 5-half-lives (whichever is longer) prior to Visit 1
- Participants who have received any monoclonal Antibody (mAb) within 130 days or 5-half-lives (whichever is longer) of Visit 1. Authorised treatments for Coronavirus disease 2019 (COVID-19) are permitted and should be used in line with local regulatory guidance
- Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products)
- Participants who have received treatment with an experimental anti-inflammatory drug (non-biologicals) within 3 months prior to Visit 1
- Concurrent enrollment in another clinical trial
- Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1
- Participants with allergy/intolerance to a mAb or biologic or any of the excipients of the investigational products
- Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
- Liver safety exclusion criteria: Participants who meet the following criteria based on results from the sample taken at Screening Visit
- Alanine aminotransferase (ALT) greater than (>)2 * Upper limit of normal (ULN)
- Total bilirubin >1.5 * ULN; for participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is less than or equal to (=<) 1.5 * ULN
- Cirrhosis or current liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice
- An abnormal Electrocardiogram (ECG) finding from the 12-lead ECG conducted at Screening, if considered clinically significant and likely to impact the participant's study participation, based on the evaluation of both the investigator and a pediatric cardiologist, or measured results of QT Corrected for Heart Rate using Fridericia's Formula (QTcF)
- >460 milliseconds (msec)
- >480 msec for participants with bundle branch block
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Colorado Springs, Colorado, 80923
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Mobile, Alabama, 36608
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Watertown, South Dakota, 13601
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old
This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability.
- Conditions
- Asthma
- Being tested
- Depemokimab
- Keywords
- Depemokimab, GSK3511294, Asthma with Type 2 Inflammation, Pediatric Asthma, Eosinophilic Asthma, Eosinophilic phenotype
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepemokimabBiological
Also called GSK3511294
Depemokimab will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Depemokimab | Experimental | Participants will receive depemokimab at doses based on their body weight. Receives: Biological: Depemokimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depemokimab Concentration in Plasma
Measured: Up to Week 52
Secondary outcomes (5)
Number of Participants with Adverse events (AE) and Serious Adverse Events (SAE)
Measured: Up to Week 52
Number of Participants with Clinically Significant changes in Clinical Safety Laboratory Parameters
Measured: Up to Week 52
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to Week 52
Number of Participants with Positive Anti-Depemokimab Binding Antibodies and Neutralizing Antibodies
Measured: Up to Week 52
Ratio to Baseline in Absolute Blood Eosinophil Count
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start25 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion24 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671001
- Sponsor's protocol ID
- 213204
- Acronym
- GLIDE
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old
- ClinicalTrials.gov ID
- NCT07671001
- Acronym / sponsor ID
- GLIDE / 213204
- Conditions
- Asthma
- Keywords
- Depemokimab, GSK3511294, Asthma with Type 2 Inflammation, Pediatric Asthma, Eosinophilic Asthma, Eosinophilic phenotype
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 24 Nov 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at assessing depemokimab as an add-on medicine for the treatment of asthma with type-2 inflammation in participants of 6 to 11 years of age. This study will test how the body processes depemokimab, how the drug works in the body, and its safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depemokimab | Experimental | Biological: DepemokimabParticipants will receive depemokimab at doses based on their body weight. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Participants who have a documented physician diagnosis of asthma for at least 12 months prior to Visit 1 that meets the National Heart, Lung, and Blood Institute guidelines [NHLBI, 2007] or Global Initiative of Asthma (GINA) guidelines [GINA, 2025] or Japanese Pediatric Guidelines for The Treatment and Management of Asthma [JPGL, 2023]
- Asthma with type 2 inflammation characterised by an eosinophilic phenotype as indicated by: elevated peripheral blood eosinophil count of greater than or equal to (>=)300 cells/microliters (mcL) demonstrated in the past 12 months, or elevated peripheral blood eosinophil count of >=150 cells/ mcL at visit 1
- Participants who are >=15 Kilograms (kg) in body weight
- A well-documented requirement for regular treatment with inhaled corticosteroid (>=200 mcg/day fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). The Inhaled corticosteroids (ICS) dose should represent medium or high dose in children aged 6-11 years of age
- Current treatment with an additional controller medication for at least 3 months prior to screening [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline]. For Japan only: This inclusion criterion does not apply to the participants in Japan. As long as the ICS dose represent high dose, the current treatment or previous failure of an additional controller will not be required for eligibility
Key exclusion criteria (21 listed)
- Participants with any history of life-threatening asthma (e.g. requiring intubation and assisted ventilation), immunosuppressive medications intake with the exception of oral CS for asthma, or immunodeficiency disorder
- Or presence of a known pre-existing, clinically important lung condition other than asthma
- Participants with other conditions that could lead to elevated eosinophils
- Participants who have known, pre-existing, clinically significant medical conditions that could affect the conduct of the study
- Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis excluded prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepemokimabAlso: GSK3511294Depemokimab will be administered. | Biological | Depemokimab |
Primary outcome
Depemokimab Concentration in Plasma
Time frame: Up to Week 52
5 secondary outcomes
Number of Participants with Adverse events (AE) and Serious Adverse Events (SAE)
Time frame: Up to Week 52
Number of Participants with Clinically Significant changes in Clinical Safety Laboratory Parameters
Time frame: Up to Week 52
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Week 52
Number of Participants with Positive Anti-Depemokimab Binding Antibodies and Neutralizing Antibodies
Time frame: Up to Week 52
Ratio to Baseline in Absolute Blood Eosinophil Count
Time frame: Up to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depemokimab Concentration in Plasma (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.